Documents submitted to the FDA’s CBER and CDER must comply with the agency’s PDF specifications regarding link appearance.
Both agencies prefer blue text for hyperlinks in PDFs created from electronic source files. For scanned documents, hyperlinks should be a thin blue line.
|Electronic Source File
If you are creating documents in Microsoft Word, it is best to style the text blue, or edit your styles to include the color, then convert to PDF.
Regulatory professionals often have to work with scanned documents, or PDFs authored outside of their control. For these documents, a post-process is required to bring link appearance into compliancy.
In this article, I’ll discuss how to change link color and style.
I recently received the following inquiries from customers::
Some of my Excel files contain more than one worksheet. I would like to convert the second worksheet in an Excel file to the same PDF.
I have over 1000 Excel documents to convert to PDF as part of a regulatory filing. Is there a way to convert these all to PDF in batch?
I’ll tackle both of these needs in this article.
Converting Multiple Worksheets
Fortunately, Acrobat 8 and later can easily convert all of the worksheets in your Excel files to PDF:
When you use the PDF Maker in Acrobat 9, you have some additional options to select just the worksheets needed:
A) Choose options to convert all worksheets, the currently selected worksheet or a subset of the worksheets.
B) To choose some worksheets, but not others, select from the list on the left and use the Add or Remove buttons to move them to the list on the right.
C) Click the Convert to PDF button to complete the process
The result is a nicely bookmarked PDF that looks like this:
What about batch conversion?
If you want to convert many Excel documents in batch to PDF, there are a few additional tricks involved. Read on learn how in the rest of the article.
The pharmaceutical industry uses a lot of data. Consequently, we see a lot of tabular data converted to PDF documents. It is common to see lab instrument data, database reports and enterprise systems data output as PDF.
So, there you are, alone in your office staring at a PDF document wishing you had access to the original data. What do you do?
Fortunately, Acrobat 9.1 offers a couple of different ways to export to Excel.
- Select table and open in Excel
This allows you to select a portion of a page and open it in Excel.
- Export as Tables in Excel
This method uses some artificial intelligence to convert multiple page PDF documents to multiple worksheets in an XML-based spreadsheet file. It works best on files which were converted directly from Excel to PDF.
Acrobat generally will usually do a pretty good job converting the text, but formatting and column widths will look different than the original. Acrobat only copies over the text. Formulas will not convert. Do not expect 100% fidelity.
In the full article, you’ll receive my usual step-by-step instructions.
Adobe recently released security updates to Acrobat and Adobe Reader 7, 8 and 9.
Large Life Science corporations centrally distribute software to users, most often on the Windows platform.
In this article, I’ll discuss the tools and techniques that are available to help IT personnel deploy and update versions of Acrobat 7, 8 and 9, including the free Adobe Reader.
First, I’ll show you where you can download the apps and our tools for deployment. In the full article, I’ll discuss how to “chain” installs, expand Adobe Reader, and use the Adobe Customization Wizard to streamline installation.
Get the Updates and the Deployment Tools
Various updates are available depending on the version of Acrobat and/or Reader you have installed. To make it easier to customize Acrobat, Adobe offers installation tools which help you remove earlier versions of Acrobat, serialize the product, and set a wide variety of program options.
The links below are for Windows versions. Mac Acrobat users can find updates here.
Adobe generally does not issue complete, new packages for dot releases, so it’s important to properly “chain” these installs. I’ll also discuss how to expand the Adobe Reader to make it installable, and discuss the Acrobat Customization Wizard and other resources available. Read on for this information.
NOTE: If you receive my blog via email, make sure you click on the article title to read it on my blog.
Today, my colleagues Mark Middleton, Ed Chase and I conducted a joint eSeminar with the SAFE Bio-Pharma Association called:
Using SAFE- BioPharma Digital Signatures in Adobe Acrobat 9
I’ll post a link to the recording soon.
I’ve included three downloads that you might find useful:
- Adobe Acrobat Slides
Go over the digital signing process in Acrobat
- SAFE Slides
Covers the business benefits of using SAFE signatures
- Adobe LiveCycle eSubmissions Solutions Accelerator
Slides on Adobe’s server-based review and approval systems which can be part of an audited, CFR-Part 11 workflow
- Digital Signatures Cheat Sheet
Helps you understand the various status messages associated with digital signatures
Read on to get the good stuff.
If you attended my eSeminar "
Regulatory Compliant PDFs and Beyond
" and are looking for a copy of the slides and other materials, you’re in the right place.
One point I try to get across about Acrobat is that it can be used for far more than just creating a PDF as part of an electronic submission.
Acrobat is terrific as a general tool for any knowledge worker. Need to capture information from a web site? Scan in paper documents? Combine files into something well-organized to send out?
Yes, yes, yes.
Click on the Continue Reading link below to access two documents:
- Slides from the events
- Comparison of Acrobat features from version 7, 8 and 9
Did you attend the
PDF Document Review eSeminar:
Ad Hoc or Audited Options for Life Sciences
I’ve posted two sets of slides. The first set covers Shared Review in Acrobat. The second set covers the LiveCycle eSubmissions Solution Accelerator.
To recap, the seminar covered:
Adobe experts will show you how to encourage active participation by your employees and accelerate the document review process. Whether you need informal document review or an audited CFR-Part 11 compliant review process, Adobe offers solutions which leverage the Adobe Acrobat product family, including the free Adobe Reader.
Attend this free seminar and you will:
- Learn how to enable ad hoc review workflows using Adobe Acrobat and the free Adobe Reader
- Discover how Adobe LiveCycle server solutions can create, route and manage audited review processes
- See how multiple users, in real time, can add notes and comments to PDF documents
- Discover how to create custom stamps and other annotations
- Find out how to use network folders or Microsoft SharePoint to host ad hoc reviews
Click onward to download the slides . . .
One requirement for scanned PDFs submitted to most regulatory agencies is that the files are searchable. To make scanned PDFs text searchable, Optical Character Recognition (OCR) is used.
In a previous article on Batch OCR, I discussed using Acrobat Pro to create a Batch Sequence to process multiple files.
In Acrobat 9 Standard and Pro, there is now an easy way to OCR multiple files using a new feature— Recognize Text in Multiple Files using OCR:
Read on to learn how to use this new feature.
Adobe Reader 8.13 and Adobe Acrobat 8.1.3 are now available:
Acrobat 8 Win
Acrobat 8 Mac
Adobe Reader (All)
The Reader update is also available via FTP:
The Adobe Acrobat/ Reader 8.1.3 update addresses a number of customer workflow issues and security vulnerabilities while providing more stability.
Note: Acrobat 9.0 and Adobe Reader 9.0 do not require a security update.
The Acrobat/Adobe Reader 8.1.3 Release Notes contain an exhaustive list of the fixes.
Many of the fixes address dynamic forms issues. If your organization uses dynamic forms and Adobe’s LiveCycle server products, you should carefully read the Release Notes above.
Acrobat 8.1.3 also addresses some critical security issues.
You might want to read the Acrobat 8.1.3 Security Bulletin.
Today, my colleague Mark Middleton and I presented an eSeminar:
As I mentioned in a recent article Capture Discoveries in a PDF Lab Notebook, PDF Portfolios offer an interesting platform for preserving scientific research.
Read on for a link to the slides from the event.